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- 2026-04-12 22:51:50
- Company
- AstraZeneca wins second trial on ‘Forxiga substance patent'
- by Kim, Jin-Gu Feb 18, 2022 05:55am
- AstraZeneca, the original drug maker of the SGLT-2 inhibitor for the treatment of diabetes, ‘Forxiga,’ won the second trial over its substance patent. The ruling has abruptly put a hold on Dong-A ST’s plans for the early release of its Forxiga latecomer. The industry interpreted this as a crisis for the ‘pro-drug strategy’ that has been gaining attention as a breakthrough in overcoming the substance patent of originals. On the 17th, the Patent Court of Korea overturned the first instance court ruling and ruled in favor of AstraZeneca in its appeal against Dong-A ST to overrule the Intellectual Property Trial and Appeal Board (IPTAB)’s decision. The IPTAB had previously ruled in favor of Dong-A ST. The Patent Court of Korea judged that the Forxiga prodrug (product name Dapaflo) falls within the scope of the patent of AstraZeneca's Forxiga’s active ingredient. The ruling has put a stop to Dong-A ST’s early release strategy. Dong-A ST had planned to release a Forxiga latecomer exclusively if it wins in the appeal. However, losing the second trial, Dong-A ST can now only release its latecomer drug after April 7th 2023, after Forxiga’s substance patent expires. The prodrug strategy that gained industry interest is also in peril. Dong-A ST was the first in Korea to attempt evasion of Forxiga’s substance patent using the prodrug strategy. The industry believed that this attempt may become a new breakthrough in overcoming the 'impenetrable' substance patents of original drugs. Pro-drug is a ‘pro’ drug that is considered a similar but different drug from the original drug. Its chemical structure is partially different in its substituents with the original drug until administration. However, once administered, the drug shows the same effect as the original drug. In principle, it may seem similar to salt-modified drugs, but the difference Is clear. Salt can be changed through simple ion bonding, and the chemical structure of the drug does not change. However, prodrugs change the substituents through a more difficult covalent binding method. It has a different chemical structure to the original drug. The key issue in the patent suit was whether a prodrug could be considered a completely new substance. The Patent Court of Korea had determined prodrug partially improved form an existing substance.
- Company
- The industry is worried about the spread of Omikron
- by Kim, Jin-Gu Feb 18, 2022 05:55am
- The Omicron mutation COVID-19 virus is also hurting factories and research institutes of pharmaceutical bio companies. Concerns are growing over production disruptions as a series of confirmed cases have emerged in Hwaseong Hyangnam Pharmaceutical Industrial Complex and Cheongju Osong Life Science Complex, where pharmaceutical factories are concentrated. According to the pharmaceutical industry on the 15th, a series of COVID-19 confirmed cases have recently occurred in the Hyangnam Pharmaceutical Industrial Complex located in Hyangnam-eup, Hwaseong-si, Gyeonggi-do. It is reported that the number of confirmed cases is increasing after the Lunar New Year holiday. Currently, 40 factories of 38 pharmaceutical companies are in operation in the Hyangnam complex. There are 3,500 workers working in the complex alone. Most of them commute from Suwon or Hwaseong, Gyeonggi-do. The problem is the spread of COVID-19 in Suwon According to Gyeonggi-do, as of midnight on the 15th, there were 31,894 confirmed cases of COVID-19 in Suwon. The number of new confirmed cases is 1,387. In the case of Mars, a total of 27,039 people, including 1,589 new confirmed cases. Analysts say that the Hyangnam Pharmaceutical Industrial Complex has also been affected by the rapid spread of COVID-19 in Suwon. The pharmaceutical industry is concerned that if the spread continues, drug production will be disrupted. Currently, most of the factories in the Hyangnam Pharmaceutical Industrial Complex are reported to take self-quarantine measures for a certain period of time for COVID-19 confirmed patients and all departments. In addition to the government's guidelines for self-quarantine of COVID-19 confirmed patients for a week, it is interpreted as a measure to prevent further spread of COVID-19. An official from the pharmaceutical industry working at the Hyangnam complex said, "Unlike the early days of the COVID-19 crisis, the entire factory will not be shut down," adding, "The number of confirmed cases has been increasing recently as the Omicron mutation spreads so rapidly. In particular, there seems to be a series of confirmed cases after the Lunar New Year holiday, he said. He said, "There are places where all employees of the department are quarantined for a week when a confirmed person comes out, and some places take measures not to go to work until the infection of fellow employees is confirmed," adding, "Since the factory cannot work from home, everyone seems to be nervous about whether there will be a confirmed person." The self-quarantine rules have also been greatly strengthened recently, he added. Another pharmaceutical industry official said, "As quarantine is carried out on a team or department basis, if at least one confirmed person comes out, the operation of the line will be disrupted," adding, "Even if workers from other lines return their vacations and are put in, production delays are inevitable." Concerns are also growing at the Osong Life Science Complex located in Osong-eup, Cheongju-si, Chungcheongbuk-do. The Osong Life Science Complex currently houses more than 70 companies and research institutes related to medicines, medical devices, cosmetics, and food. About half of them are pharmaceutical bio companies. As of 8 a.m. on the 15th, 710 new COVID-19 confirmed patients were confirmed in Cheongju, Chungbuk, where Osong Complex belongs. Currently, 6,368 people have been confirmed and are in self-quarantine. The pharmaceutical industry predicts that the occurrence of confirmed cases in Osong Complex will also be a matter of time. An official from the pharmaceutical industry said, "The current spread is so fast that there is nothing strange about it even if a confirmed person comes out at any time," adding, "The problem is that it is difficult to find substitute manpower." If there are one or two confirmed cases, it will be okay, but if there are several confirmed cases, it is expected that the production schedule will be tight."
- Policy
- What is the pledge of the presidential candidates?
- by Lee, Jeong-Hwan Feb 18, 2022 05:54am
- Democratic Party of Korea Lee Jae-myung (left), the power of the people, Yoon Seok-yeolWith the 20th presidential election day just 20 days away, candidates from each party completed submitting their teenage pledges with the registration of candidates for the National Selection Commission on the 13th. The main keyword for the health care pledge of Democratic Party of Korea Lee Jae-myung, the power of the people Yoon Seok-yeol, Ahn Cheol Soo of the People's Party, and Sim Sang Jung of the Justice Party is "overcoming COVID-19." Lee Jae-myung promised to secure sovereignty in domestic development vaccines and treatments and establish a public production system for essential medicines based on the strengthening of the all-out response system to the spread of COVID-19 variants such as Omicron. Lee Jae-myung plans to strengthen his ability to respond to infectious diseases by securing sufficient public hospitals and public medical personnel. Earlier, he said he would also implement policies to apply health insurance for hair loss treatments and legislate CCTVs in operating rooms, which he had pledged to "small situations" and Lee Jae-myung's definite happiness). Candidate Yoon Seok-yeol of the People's Power pledged to immediately operate an emergency rescue program by setting up a "COVID-19 Emergency Rescue Special Headquarters" directly under the president's office. Candidate Yoon established a policy fee in the health insurance benefit system to strengthen periodic pandemic responsiveness and announced the realization of a national responsibility system for essential medical care. It also reaffirmed its pledge to strengthen the requirements for foreign health insurance subscribers to register dependents and prevent theft of their names. Candidate Yoon is also expected to apply health insurance for consecutive blood glucose meters for diabetic patients, expand mobile telemedicine for military personnel, and make it mandatory to check health insurance recipients of medical institutions. Candidate Ahn Cheol Soo The People's Party stands out in the health and medical field for pledges such as safe welfare by life cycle, lowering the price of hair loss generic drugs, and the state responsibility system for mental health. Candidate Ahn promised to raise 3 trillion won to 5 trillion won in finances used to abolish standards for livelihood and medical benefits in order to link and treat high-risk groups for depression by adding mental health checkups to the entire nation. Candidate Sim Sang Jung Justice Party put the so-called "Sim Sang Jung Care" at the forefront of the pledge, which guarantees the right to health for the people by expanding public health care and setting an annual cap of 1 million won for hospital expenses. From the cradle to the grave It is determined to ensure the care of the whole people. As a way to implement Sim Sang Jung care, the government has proposed the expansion of public health care, guaranteeing essential severe medical care by region, upper limit on hospital expenses, and realizing health advanced countries such as the family doctor system. In detail, it promised to establish a system for training public doctors and public nurses by establishing the National University of Medicine and public medicine, and to expand health care personnel to the OECD level. It also said it would conduct a health impact assessment on all government policies with the establishment of the Ministry of National Health.
- Company
- The development of next lung cancer txs is in full swing
- by Feb 17, 2022 05:53am
- From the left, Lumakras, Rybrevant & TabrectaStarting with EGFR, treatments have been released. The first dual inhibitor was also released. Non-small cell lung cancer treatment is facing a new turning point with the emergence of various targeted anticancer drugs. Precise treatment began by pioneering areas where there were no treatments, such as KRAS, MET, and EGFR Exon 20. ◆ New KRAS drug in 40 years, 8 global companies will develop For the first time in 40 years this year, a new drug targeting KRAS mutations has emerged. It is Amgen's Lumakras, approved by the MFDS on the 14th. Lumakras can be used as a secondary treatment for KRAS G12C mutation local progression or metastatic non-small cell lung cancer. Non-small cell lung cancer patients show various genetic mutations, and KRAS mutations account for the largest proportion of them. About 25% of the world represents KRAS mutations. In Korea, it is about 5 to 8%. Lumakras succeeded in entering the KRAS field for the first time. The KRAS tumor gene was discovered early in 1982, but it did not lead to the development of a treatment. This is because clinical trials have repeatedly failed due to the complex molecular biological activity mechanism of KRAS. The binding site was also very small, so the development of target materials was a challenge. Starting with Lumakras, KRAS target treatments are expected to appear one after another. This is because many global pharmaceutical companies have entered the development of KRAS-targeted anticancer drugs. Eight companies, including ▲Mirati Theraputics ▲ Novartis ▲ Roche ▲ Boehringer Ingelheim ▲ MSD ▲ Eli Lilly ▲ Sanofi ▲ InventisBio, are conducting KRAS clinical trials in Korea. Among them, Mirati is closely chasing Amgen as the most advanced step. Mirati's Adagrasib is undergoing phase 3 in Korea and is undergoing FDA approval review in the United States. The development of other pharmaceutical companies is in phase 1/2. ◆Dual inhibiton of EGFR and MET have also emerged Treatment of non-small cell lung cancer is facing a new turning point. For non-small cell lung cancer, targeted treatment began with the emergence of Iressa, the first EGFR target anticancer drug, and in 2017, immuno-cancer drugs entered and presented a new paradigm for the treatment of non-small cell lung cancer, which cannot be used. Recently, the area of anticancer drugs targeting non-small cell lung cancer has increased further. In addition to relatively common KRAS mutations, minority mutations found in less than 3% of all patients can be detected. Janssen's Rybrevant, which was approved by the MFDS on the 15th, shows a clear difference from the existing EGFR targeted anticancer drugs. It aimed at a blind spot called Exon 20 insertion mutation, not Exon 19 defect and L858R substitution mutation, which are common in EGFR. EGFR Exon20 insertion mutation non-small cell lung cancer is rarely found as the third most common mutation among EGFR mutations. Rybrevant is clearly different in that it targets not only EGFR but also MET variations. With the approval of Rybrevant, the EGFR target anticancer drug market is also expected to change. Already, in the EGFR area, third-generation drugs represented by Tagrisso and Leclaza through the first and second generations are becoming standard treatments. Although it remains in the second treatment due to clinical problems in Korea, global guidelines have already recommended the third generation Tagrisso as the top priority treatment. A new anticancer drug that directly targets MET gene mutations also appeared for the first time last year. It is Novartis' Tabrecta and Merck's Tepmeko. Both drugs, which were approved by the MFDS side by side in November last year, can be used in patients with local progressive or metastatic non-small cell lung cancer whose MET exon 14 deficiency was confirmed. MET mutation is also one of the genetic mutations caused by non-small cell lung cancer. The adverse reactions in the MET gene are largely divided into MET amplification and MET mutation, and the MET exon14 defect targeted by Tabrecta and Tepmeko is a representative MET mutation. Targeted anticancer drugs targeting RET genes are also expected to be released soon. Roche and Lilly are undergoing domestic approval procedures for their own Gavreto and Retevmo. These drugs can inhibit primary mutations in the RET gene as well as secondary mutations that cause anticancer treatment resistance. The incidence of RET mutations in non-small cell lung cancer is reported to be around 2%.
- Opinion
- [Reporter’s View] Why set deadlines in pricing negotiations
- by Eo, Yun-Ho Feb 17, 2022 05:53am
- A deadline is a pre-determined set amount of period. If this period is extended frequently, what meaning would setting a ‘deadline’ have? This question arises with the uprise of deadline extensions being made in the drug pricing negotiations between the National Health Insurance Service and pharmaceutical companies for reimbursement listing or reimbursed indication extensions. Simply put, too many ‘exceptions’ are being made. When the drug pricing negotiation period for the 3rd generation lung cancer treatment ‘Tagrisso (Osimertinib)’ was extended five years ago, the media had described the extension as ‘exceptional’ or ‘unprecedented.’ However, so many drugs, especially anticancer drugs, have recently failed to reach negotiations or completed negotiations after the deadline. Even now, more than 3 drugs are in negations past their deadlines. This is why pharmaceutical officials awaiting negotiations sometimes make jokes that “We wouldn’t be able to complete negotiations at once, but maybe during the extended period.” With the introduction of the effective but high-priced drugs, the increased extensions, and exceptions may be implying that the ’60 day’ negotiation period is now not sufficient time for the government pharmaceutical companies to reach an agreement. However still, a deadline is a deadline. Moreover, the reduction of the negotiation period is being used as an incentive and a benefit. In other words, the period was set to accelerate listing and limit the final period of negotiations and allow predictability of listings. However, no either party is fully accountable. The common period extensions, the introduction of more expensive and difficult-to-negotiate drugs, and the lack of determination to produce results within the deadline have led to a repetition of such ‘exceptions.’ Also, the companies’ dragging out negotiations due to delay in communication with its headquarters, and the administrative department’s complacency in postponing the immediate breakdown of negotiations fearing the rush of complaints from patients, undermines the purpose of the system. If discussions became difficult, strengthen the conditions for initiating negotiations. The required documentation should be reviewed and discussed with the NHIS in advance at the HIRA review stage, and the parties should be pressed to complete the negotiations within the set period. Do it “for the patients,’ that both parties have frequently referred to. Frequent exceptions are no longer exceptions.
- Company
- Seqirus “to supply next-gen influenza vaccine” in Korea
- by Feb 17, 2022 05:53am
- A new competitor has entered the influenza vaccine market. Seqirus, a subsidiary of the Australia-based biotech firm CSL, will be entering the Korean market in earnest in the COVID-19 pandemic. Seqirus Korea held an online press conference to celebrate the official launch of its Korean subsidiary on the 16th. At the conference, Seqirus threw its hat into the Korean flu vaccine market with its self-developed next-generation vaccine. At the conference, Gee-Seung Yoo, CEO of Seqirus Korea said, “Our global office is deeply interested in the significance and potential held by the Korean market. With our official launch, we hope to establish various partnerships in Korea.” Seqirus is a vaccine company parented by the Australia-based pharmaceutical company CSL. The company is known for its extensive influenza vaccine portfolio that covers a wide range of egg-based, cell culture-based, adjuvanted vaccines. Its vaccines, which are produced in 5 global vaccine manufacturing facilities, are supplied to over 20 countries including the UK, Australia, the US, and Canada. Seqirus planned its entrance into the Korean market due to COVID-19. As the Korean vaccine developer, SK Bioscience was unable to manufacture its influenza vaccines due to the manufacture of consigned COVID-19 vaccines. As egg-based flu vaccines cannot be used on patients with egg allergies, the Korean government had to urgently bring in Seqirus’ vaccine due to this temporary gap in cell culture-derived influenza vaccines that had been solely produced by SK Bioscience in Korea. Using the opportunity as momentum, Seqirus made the decision to start directly supplying its egg-based Afluria that had been marketed through Boryung Biopharma until then. Seqirus has extensive vaccine development experience that goes back over 100 years. It owns both egg-based and cell culture-derived flu vaccines and became the first company in the US to receive approval for an adjuvanted flu vaccine in 2020. With the launch of its subsidiary in Korea, Seqirus plans to introduce its cell culture-derived flu vaccine ‘Flucelvax’ and its adjuvanted flu vaccine ‘Fluad’ in Korea. The company is known to have high expectations for its adjuvanted flu vaccine. General flu vaccines can be less effective in immunocompromised elderly, or when the vaccine strain does not match with the one in circulation, or due to egg adaptations, etc. In such cases, adjuvanted flu vaccines can improve immune reactions and increase the prevention effect. Seqirus’s adjuvanted flu vaccine ‘MF59’ uses squalene that is produced in the liver. MF59 induces an immune response in the injection site and promotes antigen uptake to increase immune response by activating T cells and B cells. Jonathan Anderson, Medical Head of the International Region of Seqirus said, “The use of adjuvants triggers a broader and stronger antigen response and induces longer antigen response. If the MF59 that was first applied to a trivalent vaccine is applied to a quadrivalent vaccine, we will be able to achieve a strong antibody response even with a small amount.” In addition, Seqirus plans to develop various next-generation influenza vaccines including high-dose adjuvanted cell culture-derived vaccines and mRNA vaccines. Gee-Seung Yoo, CEO of Seqirus Korea said, “As Korea’s healthcare partner, Seqirus Korea will be at the forefront of the to protect public health from influenza viruses. We will work our best to promptly introduce and supply the company’s various vaccines in Korea.”
- Policy
- Rybrevant has been approved in Korea
- by Lee, Tak-Sun Feb 17, 2022 05:52am
- Janssen's Rybrevant, which is conducting a combined clinical trial with Leclaza, a new non-small cell lung cancer treatment drug developed by Yuhan Corporation, has been approved in Korea. The MFDS approved Janssen's Rybrevant on the 15th. This drug is used for "the treatment of patients with local progressive and metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations in which the disease progressed during or after platinum-based chemotherapy." The recommended dosage also varies depending on the patient's weight with intravenous injections. The drug is drawing particular attention because it is conducting clinical trials in combination with Leclaza of Yuhan Corporation, a new domestic development drug, in the global market. Lazertinib exported technology worth 1.4 trillion won to Janssen in 2018. Since then, Janssen has been conducting clinical trials on non-small cell lung cancer patients using Lazertinib and its own developed Amivantamab. Two phase 3 clinical trials are underway in Korea. The phase 3 clinical plan was approved in September 2020 as the first treatment for patients with EGFR mutant local progressive and metastatic non-small cell lung cancer. In December of last year, EGFR-mutant, which failed Tagrisso treatment, entered phase 3 clinical trials for patients with local progressive and metastatic non-small cell lung cancer. Tagrisso is a third-generation treatment for EGFR mutated non-small cell lung cancer, and is a large drug with annual sales (based on IQVIA) exceeding 100 billion won in Korea. Leclaza and combination therapy of Leclaza-Amivantamab are expected to be competitive drugs for Tagrisso. Lazertinib expects conditional approval from the U.S. FDA this year as a second and third treatment for non-small cell lung cancer. In addition, combination therapy of Amivantamab-Lazertinib also challenges FDA approval. Rybrevant was approved by the MFDS as a GFR exon20 mutant non-small cell carcinoma treatment, but it was also approved by the U.S. FDA as a therapy that blocks epithelial cell growth factor (EGFR) and MET mutations at the same time.
- Policy
- Revised the method of Rx notes for health functional foods
- by Lee, Jeong-Hwan Feb 17, 2022 05:52am
- Regarding the regulation of "Note Prescription of Health Functional Foods," the MFDS expressed its position to push for legislation after watching the operation of the prohibited regulation that the health functional food industry voluntarily announced. The government plans to steadily monitor the operation of fair competition rules, draw up policies to support voluntary improvement in the health functional food industry, and review the need to revise health functional foods in earnest according to the results. This is the result of examining the prescription management plan for health functional food submitted by the MFDS to the National Assembly's Health and Welfare Committee on the 13th. Representative movements to pay attention to in order to improve the practice of prescribing health functional foods are the legislation of the National Assembly and the enactment of fair competition rules in the Fair Trade Commission and the Health Functional Food Industry. In the case of legislation, Rep. Kim Woni of the Democratic Party of Korea has proposed a revision to the medical law, and the Fair Competition Rules will take effect in April, discussed by the Fair Trade Commission and the KHSA. The revision to the Medical Service Act stipulated that doctors and medical institutions are not allowed to receive rebates such as money and entertainment provided by health functional food companies. The Fair Competition Rule is a method in which the health functional food industry voluntarily imposes penalties of less than 10 million won and heavy penalties of less than 100 million won when detecting rebates such as expedient health functional food note prescriptions. Some worry that the revision of the Health Functional Food Act should be promoted separately from the revision and enforcement of the Fair Competition Rules to regulate the prescription of health functional food, but the MFDS, which is in charge, is in a position to watch the operation of the Fair Competition Rules. Although the MOHW and the specialized committee of the Health and Welfare Committee expressed their position that the Health Functional Food Act needs to be revised prior to the revision of the Medical Service Act, the MFDS insisted that the need to revise the law be slowly considered. The MFDS argued that medicines and medical devices also implemented fair competition rules in the industry first and then revised related laws over a period of time. In the case of medicines, the Pharmaceutical Affairs Act was revised in 2010 after the enactment of the protocol in 1994, and the MFDS explained that the Medical Device Act was revised in 2013 after the enactment of the protocol in 2011. The health functional food-style note prescription does not directly affect health insurance finances, and unlike medicines and medical devices, the reality that health functional foods have open consumer options also affected the direction of the MFDS' policy operation. As a result, it is expected that the revision of the Health Functional Food Act will become a reality depending on the results of the enactment and enforcement of fair competition rules in the health functional food industry this year. The MFDS said, "We will continue to monitor the operation of fair competition rules while supporting voluntary improvement in the industry," and explained, "According to the results, we will review the need to revise the Health Functional Food Act." Health functional foods have a variety of sales channels such as the Internet, large discount stores, pharmacies, multi-level, door-to-door sales, and home shopping, so consumers can choose them, and medicine and medical devices have also been revised since the enactment of the rules, the MFDS added.
- Company
- Roche's Polivy can be prescribed at Big 5 hospitals
- by Eo, Yun-Ho Feb 16, 2022 05:51am
- The new lymphoma drug Polivy can be prescribed at the Big 5 General Hospital. According to related industries, Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Seoul National University Hospital, and Antibody-drug conjugate (ADC) Polivy, which combines with existing BR therapy (Bendamustine & Rituximab) for treatment of Diffuse Large B-Cell Lympoma (DLBCL) with a poor prognosis. In the case of Severance, the code was generated with emergency DC. However, Polivy is still a non-reimbursed drug. Roche submitted an application for registration of Polivy's insurance benefits in February last year, but failed to pass the HIRA Cancer Disease Review Committee in April of the same year. Roche plans to continue his efforts to register Polivy in the future. Diffuse large B-cell lymphoma belongs to aggressive lymphoma that requires immediate treatment due to the rapid progression of the disease. More than half of patients have a good treatment response rate to reach remission, but 30% to 40% of patients do not respond to the standard therapy R-CHOP or experience recurrence even after primary treatment. Although most patients experience recurrence within two years and have a only six-month survival period if they recur, diffuse large B-cell lymphoma has been an area that lacks effective treatment options. Polivy is the first ADC drug to target CD79b and has a mechanism that binds to CD79b expressed in B cells to induce apoptosis. Polivy confirmed its effectiveness through a phase 1b/2 that confirmed the clinical effectiveness and safety of Polivy combination therapy in 80 patients with recurrent or refractory giant B cell lymphoma who could not receive hematopoietic stem cell transplantation and had more than one treatment experience. The drug was also designated as a rare drug in Korea in October last year. As a result of the study, the Polivy combination therapy group showed higher Complete Response (CR) and Overall Survival (OS) extensions than the BR group. Ko Young-il, a professor of hematologic oncology at Seoul National University Hospital, said, "Polivy confirmed its usefulness through clinical trials and is a treatment option recommended in international guidelines, which is meaningful in that it has suggested a new alternative to diffuse large B-cell lymphoma treatment." Peter Welford, an analyst at investment bank Jefferies, analyzed in a memo to investors that if Polivy is used for DLBCL indications, it could achieve sales ranging from at least $2.1 billion to up to $2.4 billion.
- Policy
- Lee to pledge ‘incentives for homegrown new drugs'
- by Lee, Jeong-Hwan Feb 16, 2022 05:51am
- Presidential candidate Jae-Myung Lee of the Democratic Party of Korea is positively reviewing reinforcing incentives for new drugs that were developed by Korean pharmaceutical companies or conducted trials in Korea, establishing a megafund for the pharmaceutical industry, and introducing a pre-approval system for prescriptions of ultra-high priced drugs as pledges for the coming presidential election this year. Also, the candidate is preparing to set official pledges on establishing a public electronic prescription system, institutionalize government support for public late-night pharmacies and complete eradication of hospitals owned by non-medical personnel. The pledges above were those requested by the domestic pharmaceutical industry, pharmacists’ association, and medical field and gained consensus from the NA Health and Welfare Committee. Lee plans to disclose the details of the policy in line with the official electioneering period that starts on the 15th. Lee is known to be reviewing various specific healthcare policies that require expertise regarding non-face-to-face treatment, biopharmaceutical industry, and pharmacy industry, in addition to the public healthcare pledges that he repeatedly announced including the expansion of public hospitals and reinforcing public medical personnel. In particular, the candidate is known to have drawn a relatively detailed blueprint on the development of homegrown vaccines that have greatly increased in importance due to the prolonged COVID-19 pandemic, public manufacture of essential medicines, and national support for the pharmaceutical and bio-industry are being. More specifically, the candidate is likely to make pledges to increase the vaccine self-sufficiency rate of vaccines in the National Immunization Program and strengthen the financial and administrative support needed for the treatment of COVID-19 vaccine and treatments while building a public manufacturing system for essential drugs that are at risk of supply disruption due to low profitability. Also, the candidate is considering incentive systems and active state-driven investment in the pharmaceutical and bio-industry to make Korea a pharmaceutical and biopharmaceutical powerhouse. Lee’s plan is to establish create a public-private matching-fund type megafund to improve the support system for clinical trials and realign the compensation system for homegrown new drugs and clinical trials conducted in Korea. Also, enhancing patient access to new drugs and pre-approval system for prescriptions of ultra-high-risk or ultra-high-priced drugs are being considered as pledges. The pledges above were those that multinational pharmaceutical companies with subsidiaries in Korea had continuously requested to the National Assembly and the government. In particular, the policies requested by Korea Pharmaceutical Association and pharmacists around are also expected to be included in Lee’s pledge. Policies that establish a system for non-face-to-face healthcare that has been temporarily approved due to COVID-19 and promote a state-led public e-prescription system, and policies to expand accessibility and convenience to medication for patients with public late-night pharmacies. The state-led public electronic prescription transmission system has been a policy that KPA had requested for several years now. The public late-night pharmacies are being piloted this year after securing a budget the previous year. Lee’s aim is to expand this pilot project into a main project. In addition, to completely eradicate hospitals owned by non-medical personnel, pledges to allow judicial police power to the NHIS, voluntary reporting, immunity for whistleblowers, stronger report rewards, punishment for those who made illegal establishments, and stronger recovery of unlawful profits are also expected to be included in the manifesto. Also, Lee’s camp promised to fully include ‘small/clear happiness pledges’ Lee had made as health insurance reimbursement of hair loss treatments, contraception, and abortion, free vaccination of HPV vaccines in adolescents, and soft landing the legalization of CCTVs in the operating room. An official from Lee’s camp said, “The camp is busy making additional modifications and final touches to the manifesto. We are in the healthcare pledges are in the final stages, and review the general improvements required in healthcare from public Healthcare to pharmaceutical and bio-industry, to patient systems at hospitals and pharmacies in Korea. The official added, “due to the diverse and multifaceted range of pledges that are being discussed by Lee’s camp, some have been producing false news that Lee excluded the reimbursement pledge for hair loss drugs based on the draft prepared by the camp. The completed pledge manifesto will be disclosed on the 15th when the official election campaign begins."
